On doing a good job in the key varieties of information tracing system construction of the announcement interpretation

, drug information traceability system construction time limit requirements?Drug listing license holders shall implement the main responsibility of drug quality management throughout the process, and the holders of key varieties such as selected varieties, narcotic drugs, psychotic drugs and blood products shall complete the construction of the traceability system by December 31, 2020, and collect the traceability information of the whole process, so as to basically realize the traceability of key varieties such as selected varieties, narcotic drugs, psychotic drugs and blood products in the centralized procurement of national drugs.

, how do drug market license holders file basic information and traceability code coding rules? How do I assign a code to a product?Drug listing license holders can log on to the drug traceability collaborative service platform filing basic information and tracecode coding rules, or they can use the traceability system to file basic information and traceability code coding rules through the interface. Drug listing license holders are encouraged to use the traceability system for information filing, which includes basic information of enterprises, basic information of drugs and information of traceability code coding rules (basic information of drug traceability code issuers, coding rules, drug identification codes, production enterprises, generic names of drugs, dosage forms, preparation specifications, packaging specifications, etc.). After the approval of the record, the drug market license holders can assign the product code. For the product minimum sales packaging volume is too small or belongs to special circumstances such as special bottles, can not be assigned on the product minimum packaging varieties, can be the smallest packaging on the upper level of packaging.

third, pharmaceutical business enterprises and user units should obtain and upload drug traceability information?Drug business enterprises and user units shall be connected to the traceability system in which the drug is located. When purchasing drugs, pharmaceutical enterprises shall obtain relevant retrospective information from upstream enterprises through the traceability system, check them at the time of drug acceptance, and return the checking information to upstream enterprises through the traceability system, and provide relevant traceability information to downstream enterprises or relevant institutions through traceability systems when selling drugs. When purchasing drugs, pharmaceutical users shall obtain relevant retrospective information from upstream enterprises through the traceability system, check them at the time of drug acceptance, and return the check information to upstream enterprises through the traceability system;

the main tasks of the provincial drug regulatory authorities?The provincial drug regulatory departments should, in accordance with the regulatory needs, build the provincial drug information tracing supervision system for data collection, monitor the flow of drugs, give full play to the role of traceability information in day-to-day supervision, risk prevention and control, product recall, emergency disposal and other regulatory work; The administrative guidance and supervision and inspection of drug agency enterprises and drug management enterprises shall be urged to implement the retrospective responsibilities in accordance with the Drug Administration Law and the standards for the retrospective construction of drug information, and the retrospective system construction and retrospective information provision shall be incorporated into the daily supervision and inspection projects to ensure that the key varieties of information tracing work is carried out smoothly and completed on time.
(National Drug Administration)